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Completed

NCT Number: NCT01736462

Corneal Endothelial Cell Density Changes, When Mapracorat Ophthalmic Suspension 3%, is Administered for 14 Days

The objective of this study is to evaluate the effect on corneal endothelial cell density (cells/mm²) changes at 3 months when mapracorat ophthalmic suspension, 3% is administered QID (four times daily), for 14 days in healthy subjects with a normal ophthalmic history.

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Key information

Conditions

Corneal Endothelial Cell Changes Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bausch & Lomb Inc

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have a Pinhole visual acuity (VA) equal to or better than 20/40 in both eyes.
  • Must be in good ocular health

Exclusion criteria

  • Subjects who have known hypersensitivity or contraindication to the study drug or its components.
  • Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
  • Any topical ophthalmic medication, including tear substitutes that cannot be discontinued during the study.
  • Subjects who are monocular (fellow eye is absent or fellow eye's Pinhole VA is worse than 20/200).
  • Subjects with a history of ocular surgery, or who anticipate ocular surgery in either eye within the study period.
  • Presence of significant ocular or systemic disease that the Investigator determines could interfere with the study.

Treatment and study plan

Mapracorat

Drug

One drop of mapracorat ophthalmic suspension, 3% four times daily, at approximately four hour intervals, for 14 days in both eyes.

Primary outcomes

  1. Endothelial Cell Density

    Time frame: 3 months (Visit 4)

    The mean endothelial cell density (cells/mm2)(ECD)

Secondary outcomes

  1. Area under the plasma concentration-time curve

    Time frame: Day 1 (Visit 2)

    Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (Ct). Blood samples will be collected for the determination of mapracorat and any potential metabolite(s). Concentrations in plasma measured within 1 hour prior to dosing on day 1 (visit 2).

  2. Area under the plasma concentration-time curve

    Time frame: Day 15 (Visit 3)

    Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (Ct). Blood samples will be collected for the determination of mapracorat and any potential metabolite(s). Blood samples will be collected within 1 hour prior to dosing and at 0.25, 0.5, 1, 2, and 4 hours after a single administration of mapracorat at visit 3.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

An Open-Label Study to Evaluate 3 Month Corneal Endothelial Cell Density Changes in Healthy Subjects When Mapracorat Ophthalmic Suspension, 3%, is Administered 4 Times Daily for 14 Days

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2012
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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